Johnson & Johnson Vision Announces Availability in Europe of TECNIS Eyhance IOL, a Next-Generation Monofocal Intraocular Lens for Patients with Cataracts
TECNIS Eyhance IOL is the latest innovation in the industry leading TECNIS® Family of Intraocular Lenses
First lens (1) in the monofocal IOL category in Europe to deliver improved intermediate vision and 20/20* distance vision
TECNIS Eyhance IOL offers the same well-established low incidence of halo, glare, or starburst as TECNIS® 1-piece IOLs
SANTA ANA, Calif., Feb. 4, 2019 /PRNewswire/ -- Johnson & Johnson Vision2, a global leader in eye health, today announced the launch of its TECNIS Eyhance IOL for the treatment of cataracts in Europe. This next-generation monofocal intraocular lens (IOL) allows patients to experience high-quality vision at both intermediate and far distances. This is an important first for the monofocal IOL category, as today most lenses in the monofocal category only correct vision to help patients with cataracts see things at a distance, and thus do not improve the intermediate vision that is required for many important daily tasks.
"With the availability of TECNIS Eyhance IOL in Europe, we are proud to deliver another meaningful solution for patients with cataracts," said Tom Frinzi, Worldwide President, Surgical, Johnson & Johnson Vision3. "We saw an opportunity to build upon the legacy of the TECNIS® Family of IOLs and the proven design of our 1-piece platform to reimagine what was possible with the standard aspheric monofocal IOL."
TECNIS Eyhance IOL allows patients to achieve significantly improved intermediate vision, compared with a standard aspheric monofocal IOL, along with 20/20* distance vision. In addition, data has shown a low incidence of halo, glare or starburst (bright circles of light that surround headlights and other light sources) comparable to what has been reported with the TECNIS® 1-piece IOL. According to patient-reported outcomes, TECNIS Eyhance IOL enables most patients to perform certain activities with greater ease, such as being able to walk on uneven surfaces, and to engage in activities of personal interest, including favorite hobbies.4
"Today, patients with cataracts are forced to make a trade-off decision on their vision when selecting a monofocal intraocular lens," explained Dr. Oliver Findl, MD, MBA, Chief of Department of Ophthalmology, Hanusch Hospital Vienna and ESCRS Board Member and Secretary5. "They can have corrected vision at a distance, but require glasses for near and intermediate vision activities, which refers to everything at arm's length such as computer work or looking at a car speedometer. TECNIS Eyhance IOL offers high quality intermediate as well as distance vision, which is an important advancement to allow patients greater ease in certain activities in their day-to-day lives."
TECNIS Eyhance IOL has European CE Mark approval and is now commercially available across Europe, including UK, Italy, France, Spain and Germany. This product is not currently approved or commercially available in other countries. In some countries, TECNIS Eyhance IOL is covered by medical insurance making it an important option for patients when a monofocal IOL is being considered.
TECNIS Eyhance IOL is part of the TECNIS® Family of IOLs, which offer a variety of personalized vision options for people with cataracts, all with the goal of ensuring clear, sharp vision to meet individual needs and lifestyles. In particular, presbyopia-correcting IOLs, like TECNIS Symfony® IOL, also exist that may be able to address other visual conditions, help patients wear glasses less often, and enhance focus at a full range of vision – near, intermediate and distance.
About Cataracts
An estimated 253 million people live with vision impairment: 36 million are blind and 217 million have moderate-to-severe vision impairment.6,7 Cataracts, the leading cause of blindness globally,8 account for 35 percent of the blindness and 24 percent of the moderate-to-severe visual impairment9. More than 90 percent of people develop cataracts by age 65.10 Left untreated, cataracts cause vision to deteriorate over time. Cataract surgery is the most common surgery performed around the world.11
About Johnson & Johnson Vision
At Johnson & Johnson Vision, part of Johnson & Johnson Medical Devices Companies12, we have a bold ambition: to change the trajectory of eye health around the world. Through our operating companies, we deliver innovation that enables eye care professionals to create better outcomes for patients throughout their lives, with products and technologies that address unmet needs including refractive error, cataracts and dry eye. In communities with greatest need, we work in collaboration to expand access to quality eye care, and we are committed to helping people see better, connect better and live better. Visit us at https://www.jjvision.com/. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.
About Johnson & Johnson Medical Devices Companies
As the world's most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across surgery, orthopedics, vision and interventional solutions, we're working to profoundly change the way care is delivered. We are in this for life.
About TECNIS Eyhance IOL
Indications for Use
The TECNIS Eyhance IOL, model ICB00, is indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens extends the depth of focus, which improves vision for intermediate tasks, and provide similar distance vision as compared to a standard aspheric monofocal IOL. The lens is indicated for placement in the capsular bag only.
General Adverse Events for IOLs
Potential adverse events during or following cataract surgery with implantation of an IOL may include but are not limited to: endophthalmitis/intraocular infection, hypopyon, hyphema, IOL dislocation, cystoid macular edema, pupillary block, retinal detachment/tear, persistent corneal stromal edema, persistent iritis, persistent raised IOP (intraocular pressure) requiring treatment, acute corneal decompensation, secondary intraocular surgical intervention (including implant repositioning, removal, AC tap performed later then one week after cataract surgery, or other surgical procedure), and any other adverse event that leads to permanent visual impairment or requires surgical or medical intervention to prevent permanent visual impairment.
ATTENTION: Reference the Directions for Use for Important Safety Information.
CAUTION: Federal law restricts this device to sale and use by or on the order of a physician.
INDICATIONS FOR USE: The TECNIS Symfony Extended Range of Vision IOL, Model ZXR00, is indicated for primary implantation for the visual correction of aphakia, in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The Model ZXR00 IOL is intended for capsular bag placement only.
The TECNIS Symfony Toric Extended Range of Vision IOLs, Models ZXT150, ZXT225, ZXT300, and ZXT375, are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The Model Series ZXT IOLs are intended for capsular bag placement only.
CONTRAINDICATIONS: None.
RISKS: Even with glasses, loss of sharpness may worsen under poor visibility conditions such as dim light or fog. Patients may also notice halos, starbursts, glare, and other visual symptoms with extended range of vision IOLs. Patients should discuss all risks and benefits with their eye doctor before surgery.
WARNINGS: A small number of patients may want their Tecnis Symfony IOL removed because of lens-related optical/visual symptoms.
PRECAUTIONS: If the patient's eye is unhealthy, patients may not get full benefit of the Tecnis Symfony IOL. Patients' vision with the IOL may not be good enough to perform detailed 'up-close' work without glasses, and rarely, may make some types of retinal treatment more difficult.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding TECNIS Eyhance IOL. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson Surgical Vision, Inc., any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
TECNIS, TECNIS Eyhance and TECNIS Symfony are trademarks of Johnson & Johnson Surgical Vision, Inc. © Johnson & Johnson Surgical Vision, Inc. 2019.
* Based on a clinical study, N= 134 achieved mean 20/20 monocular pooled distance BCDVA.
1 TECNIS Eyhance IOL - Product monograph EMEA 2019, table 4.1 SC2019CT4002
2 Johnson & Johnson Surgical Vision, Inc.
3 Employed by Johnson & Johnson Surgical Vision, Inc.
4 Data on File, Johnson & Johnson Surgical Vision, Inc. 2018. DOF2018CT4015.
5 Scientific advisor (paid) to Johnson & Johnson Surgical Vision, Inc.
6 Magnitude, temporal trends, and projections of the global prevalence of blindness and distance and near vision impairment: a systematic review and meta-analysis. The Lancet website. https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(17)30293-0/fulltext. Accessed November 14, 2018.
7 Blindness and Vision. World Health Organization website. http://www.who.int/news-room/fact-sheets/detail/blindness-and-visual-impairment. Accessed November 14, 2018.
8 Priority Eye Diseases. World Health Organization.
9 IAPB Vision Atlas. http://atlas.iapb.org/global-burden-vision-impairment/gbvi-global-cause-estimates/. Accessed November 26, 2018.
10 University of Michigan Kellogg Eye Center website. http://www.kellogg.umich.edu/patientcare/conditions/cataract.html. Accessed October 28, 2017. REF2016OTH327.
11 The Journey to Femtosecond Laser-Assisted Cataract Surgery: New Beginnings or False Dawn? Trikha S, Turnbull AM, Morris RJ, Anderson DF, Hossain P.
12 Comprising the surgery, orthopedics, vision and interventional businesses within the Johnson & Johnson's Medical Devices segment
SOURCE Johnson & Johnson Vision
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